FDA.reportPublic FDA data

Unipack

Primary DI
40665973029564
Brand
Unipack
Company
UNIPACK MEDICAL CORPORATION
Model
UGC-6601-XL
Catalog number
UGC-6601-XL
Device description
FitMe Lab Coats X-Large Sky Blue
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUACCESSORY, SURGICAL APPAREL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40665973029564PackageGS15In Commercial Distribution
10665973029563PrimaryGS10
00665973029566Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4066597302956440665973029564
1066597302956310665973029563
00665973029566006659730295666659730295660665973029566

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
018319397
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029839UnipackUGC-6610-LUGC-6610-L2022-12-06
10665973029846UnipackUGC-6610-MUGC-6610-M2022-12-06
10665973029853UnipackUGC-6610-SUGC-6610-S2022-12-06
10665973029860UnipackUGC-6610-XLUGC-6610-XL2022-12-06
10665973029877UnipackUGC-6610-XXLUGC-6610-XXL2022-12-06
10665973030347UnipackUGJ-6510-LUGJ-6510-L2022-12-06
10665973030354UnipackUGJ-6510-MUGJ-6510-M2022-12-06
10665973030361UnipackUGJ-6510-SUGJ-6510-S2022-12-06
10665973030378UnipackUGJ-6510-XLUGJ-6510-XL2022-12-06
10665973030385UnipackUGJ-6510-XXLUGJ-6510-XXL2022-12-06
D784UPST0501UnipackUPST-050UPST-0502022-12-06
D784UPST0751UnipackUPST-075UPST-0752022-12-06
D784UPST1001UnipackUPST-100UPST-1002022-12-06
D784UZM30011UnipackUZM-3001UZM-30012022-12-06
D784UPP10151UnipackUPP-1015UPP-10152016-09-15
D784UPP12181UnipackUPP-1218UPP-12182016-09-16
D784UPP2231UnipackUPP-223UPP-2232016-09-15
D784UPP2251UnipackUPP-225UPP-2252016-09-15
D784UPP27101UnipackUPP-2710UPP-27102016-09-15
D784UPP27101K1UnipackUPP-2710-1KUPP-2710-1K2016-09-16

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